MEXICO

The medical device regulatory approval process

See if your device is on the COFEPRIS list of deregulated devices. If not, determine classification of your device based on rules
found in “Criteria for Medical Device Classification” published in Mexico’s Official Diary.

Low Risk Class I Class II Class III

If you have no local presence in Mexico, appoint a Mexico Registration Holder (MRH) as your in-country regulatory representative.
Your MRH manages your device application and controls your medical device registration in Mexico.

Prepare Letter of Representation for your MRH and Letter of Appointment for your chosen distributor(s) in Mexico.

If your device is already registered with the US FDA (Class I, II or III), Health Canada (Class II, III and IV only) or
Japan’s PMDA (Class II, III, IV only), your device may qualify for an equivalency review process with COFEPRIS.

If device qualifies and you opt for equivalency review:

Submit application with basic company Prepare Summary Dossier referencing prior registrations in the US, Canada or Japan,
and device information. and include associated certificates, labeling and product technical documentation. CFS or CFG will be required.
Include proof of QMS compliance from country you are trying to leverage for Mexico registration.

If device does NOT qualify for equivalency review, or you choose not to submit via this route:
Prepare a detailed Registration dossier which includes full product technical information, applicable testing results, labeling and
instructions for use. Provide copy of ISO 13485 certificate. Proof of home country approval using a CFS will be required.

Include clinical and biocompatibility

testing data in dossier submission.
Clinical trials conducted outside
Mexico will be accepted.

MRH submits Registration Dossier to COFEPRIS or Third Party Reviewer* (if applicable) for review,
along with payment for registration fees. All documents must be submitted in Spanish.

All devices must follow labeling requirements found in NOM-137-SSA1-2008. Labeling and instructions for use must be submitted in Spanish.

Certificate issued by COFEPRIS and confirmation of completed registration posted on Ministry of Health website. Registrations are valid for 5 years.

* COFEPRIS has authorized certain “third party” companies to conduct registration reviews for Class I, II and III devices. Third Party Review may reduce the review time by up to half.
Companies using the “equivalency” route cannot submit through a third party reviewer.
5038-0214

This is a simpliied overview of the process. COFEPRIS may choose to audit your submission and request more documents, which will add time to your approval.

© 2014 Emergo Group – You are welcome to publish this chart on your website, or copy it for use in presentations or other materials if it is not cropped in any way. Have comments or
suggestions about the content of this chart? Email us at marketing@emergogroup.com. Chart updated 02/2014.

Learn more about Mexico:

EmergoGroup.com/mexico
© 2014 Emergo Group Inc. – All Rights Reserved
MEXICO
Typical approval time frames for medical devices

19-24 months

25-30 months

31-36 months

36+ months
10 months

11 months

12 months

13 months

14 months

15 months

16 months

17 months

18 months
2 months

3 months

4 months

5 months

6 months

7 months

8 months

9 months
Average time from submission of

1 month
required registration documents
until approval is oficially granted
by COFEPRIS.

Low Risk

*
CLASS I - Third-Party Review

CLASS I - CA/JP/US ** ** ** ** ** ** **
Equivalency

CLASS I - Standard

*
CLASS II - Third Party Review

CLASS II - CA/JP/US ** ** ** ** ** ** **
Equivalency

CLASS II - Standard

*
CLASS III - Third Party Review

CLASS III - CA/JP/US ** ** ** ** ** ** **

Equivalency

CLASS III - Standard

= Period during which approval may occur.

NOTE: The time frames shown above are typical for the majority of medical device submissions prepared by Emergo Group but assume that your device does not contain animal tissue
or medicinal substances. Your length of approval will depend on the quality and completeness of technical documentation used in the submission, additional requirements/questions
from COFEPRIS after submission, and how much time you take to address additional information requests. Devices with existing approval in the US, Canada or Japan may qualify for an
“equivalency” process which may shorten review times by COFEPRIS. Other restrictions apply for companies claiming US FDA equivalency. Also, while many Ministries of Health publish
internal goals for registration review time frames, those should generally be viewed as “best case” scenarios and often relect working days, not calendar days. YOUR SUBMISSION(S)
MAY TAKE MORE TIME THAN WHAT IS SHOWN ABOVE.

* COFEPRIS has authorized certain “third party” companies to conduct registration reviews for Class I, II and III devices. These time frames apply only if you have elected to use a third
party to review your submission. Companies using the “equivalency” route cannot submit through a third party reviewer.

** Companies which either cannot or choose not to submit using the “equivalency” route and will not be using a third party reviewer are subject to COFEPRIS’s standard review process.

© 2014 Emergo Group – You are welcome to publish this chart on your website, or copy it for use in presentations or other materials if it is not cropped in any way. Have comments or
suggestions about the content of this chart? Email us at marketing@emergogroup.com. Chart updated 02/2014.

Learn more about Mexico:

EmergoGroup.com/mexico
© 2014 Emergo Group Inc.